Fluid sample collection container and cap with a gas permeable seal configuration

Abstract

A container assembly for collecting a fluid sample includes a collection container having a first end, a second end, and a sidewall extending between the first end and the second end, and the sidewall defining a chamber for receiving a fluid sample. The container assembly can include a container cap couplable to the collection container to at least partially enclose the first end thereof. The container cap can include a sealing interface configured to at least partially contact the collection container when the container cap is coupled to the collection container. The sealing interface can include a textured sealing surface area configured to allow air to enter or exit the container assembly while maintaining a substantially fluid-tight seal between the container cap and the collection container when the container cap is coupled to the collection container.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application Serial No. 63 / 047,051, filed July 1, 2020, entitled “Fluid Sample Collection Container and Lid with Vented Seal Configuration,” the entire disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure generally relates to a container assembly for collecting fluid samples. More specifically, this disclosure relates to a container assembly including a ventilated sealing structure between a collection container and a container lid. Background Technology

[0004] For laboratory testing of biological fluid samples such as urine, it is necessary to provide containers for collecting the fluid samples. These collection containers typically consist of cup-shaped containers with removable lids. Once the fluid sample has been collected into the container, the lid is reapplied. The collection container can then be transported to a laboratory or other testing facility, where the collected sample is extracted for testing purposes.

[0005] To simplify the sample extraction process, existing collection containers use a lid that not only covers and seals the collection container but also serves as an extraction device that allows the extraction of fluid samples. Such a lid may include a seat or cavity that supports a tube extending within the cavity to the lower end of a cup-shaped container, the tube being in fluid communication with the sample contained within the container. The tube or lid may include a needle, allowing an air-evacuated collection device (e.g., a sample collection tube) to be attached to the needle to draw a portion of the collected sample into it without removing the lid. In this configuration, the sample can be removed without spilling or contaminating the sample and / or cavity area. Subsequent samples can be extracted from the collection container using multiple collection tubes.

[0006] However, existing collection containers utilize an interface between the lid and the cup-shaped collection container that, when properly closed, hermetically seals the connection interface between the lid and the container. With this complete seal between the container and the lid, the sample collection tube can underfill when drawing fluid from the container into the evacuated collection tube. This potential underfilling is due to the vacuum generated in the headspace of the container above the fluid sample as the fluid (e.g., urine) is drawn from the container into the collection tube. The vacuum generated in the headspace makes it more difficult for the evacuated collection tube to pull the fluid from the container, creating the potential for underfilling and / or slow fill times. The problem of underfilling and / or slow fill times can be exacerbated when using older evacuated collection tubes, as these tubes themselves can not be as effective at pulling fluid from the container.

[0007] Prior designs have attempted to alleviate this problem by making the entire container assembly (and thus the headspace) larger. However, this solution results in unnecessarily large container assemblies that significantly add to material costs.

[0008] Alternatively, if the user wishes to release the vacuum, the lid must be partially opened from the collection container. However, opening of the lid can result in substantial leakage from the container during sample collection, transport, and / or storage. SUMMARY

[0009] In view of the above, there is a need for a sealing configuration between the collection container and the lid that allows for improved filling of the tube regardless of the volume of fluid within the collection container, the size of the collection container, and / or the age of the tube, while also preventing leakage of fluid from the collection container during collection, transport, and / or storage.

[0010] According to one embodiment of the present invention, a container assembly for collecting a fluid sample includes a collection container having a first end, a second end, and a sidewall extending between the first end and the second end, the sidewall defining a chamber for receiving a fluid sample. The assembly further includes a container lid couplable to the collection container to at least partially close the first end thereof, wherein the container lid includes an elongated receptacle extending into the chamber of the collection container. The receptacle includes an open end defined within an upper surface of the container lid and configured to receive a sample collection tube therein. The container lid includes a sealing interface configured to at least partially contact the collection container when the container lid is coupled to the collection container. The sealing interface includes a textured sealing surface area configured to allow air to enter or exit the container assembly while maintaining a substantially fluid-tight seal between the container lid and the collection container when the container lid is coupled to the collection container.

[0011] Optionally, the textured sealing surface area can be formed by a chemical etching process. The container cap can be threadably coupled to the collection container. In certain configurations, the collection container further includes a stop ring extending circumferentially around the collection container at a location below an externally threaded portion of the collection container. The container cap can further include a flange extending around an outer rim thereof, and wherein a lower surface of the flange is configured to contact an upper surface of the stop ring when the container cap is fully coupled to the collection container. The lower surface of the flange can include a secondary textured sealing surface area configured to allow air to enter or exit the container assembly when the container cap is coupled to the collection container. Optionally, the flange can include an internally threaded portion configured to enable the container cap to be threadably coupled to the externally threaded portion of the collection container. The flange can include a plurality of ribs extending circumferentially therearound.

[0012] According to another embodiment of the present application, a container cap for use with a container assembly for collecting a fluid sample includes a disc-shaped peripheral region, a central region located within the peripheral region, wherein the central region includes an elongated receptacle extending downwardly from the central region. The receptacle has an open end defined on an upper surface of the central region and configured to receive a sample collection tube therein. The container cap further includes a flange extending downwardly from the peripheral region, wherein the flange includes an inner surface configured to releasably engage a collection container. At least a portion of the inner surface includes a textured sealing surface area.

[0013] In certain configurations, the textured sealing surface area is formed by a chemical etching process. The inner surface can further include a threaded portion configured to enable the container cap to be threadably coupled to an externally threaded portion of the collection container. The flange can further include a lower surface, and the lower surface can include a secondary textured sealing surface area configured to allow air to enter or exit the container assembly when the container cap is coupled to the collection container. Optionally, the secondary textured sealing surface area is formed by a chemical etching process. The flange can further include a plurality of ribs extending circumferentially therearound.

[0014] According to another embodiment of the invention, a method of forming a container assembly for collecting fluid samples includes providing a collection container having a first end, a second end, and a sidewall extending between the first and second ends, the sidewall defining a chamber for receiving a fluid sample. The method further includes providing a container lid coupling to the collection container to at least partially close its first end, wherein the container lid includes an elongated reservoir extending downward therefrom, the elongated reservoir configured to receive a sample collection tube therein. The container lid also includes a flange extending around its outer edge, wherein the inner surface of the flange has a textured sealing surface region formed thereon. When the container lid is coupled to the collection container, the textured sealing surface region of the container lid contacts the surface of the collection container to allow air to enter or exit the container assembly while maintaining a substantially fluid-impermeable seal with the collection container.

[0015] In some configurations, the method further includes forming a stop ring that extends circumferentially around the collection container. The method may also include forming a secondary textured sealing surface region on the lower surface of a flange, wherein the lower surface of the flange is configured to contact the upper surface of the stop ring when the container lid is fully engaged with the collection container.

[0016] Further details and advantages of this disclosure can be understood by reading the following detailed description in conjunction with the accompanying drawings. Attached Figure Description

[0017] Figure 1 A perspective view of a collection container assembly according to one aspect of this disclosure;

[0018] Figure 2 for Figure 1 The side view of the collection container component shown;

[0019] Figure 3 for Figure 1 The side view of the container lid of the collection container assembly shown;

[0020] Figure 4A for Figure 1 A cross-sectional view of the collection container assembly shown;

[0021] Figure 4B for Figure 1 A detailed cross-sectional view of a portion of the collection container assembly shown;

[0022] Figure 5A for Figure 3 The cross-sectional view of the container lid shown; and

[0023] Figure 5B for Figure 3 A detailed cross-sectional view of a portion of the container lid is shown. Detailed Implementation

[0024] The following description is provided so as to enable any person skilled in the art to make and use the described aspects of the disclosure. Various modifications to those aspects will be readily apparent to those skilled in the art, and the generic principles defined herein can be applied to other aspects as well. Any and all such modifications, variations, equivalents, and / or alternative aspects are intended to fall within the spirit and scope of the present disclosure.

[0025] For purposes of the description hereinafter, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and derivatives thereof shall relate to the application as it is oriented in the drawing figures. However, it is to be understood that the application can assume various alternative orientations and, accordingly, such specific embodiments are by way of example only and are not intended to be limiting.

[0026] Referring to Figure 1 , a collection container assembly 20 according to one aspect of the present disclosure is shown. The collection container assembly 20 includes a collection container 22 and a container cap 24. The exemplary collection container assembly 20 according to the present disclosure can be used to safely collect a fluid sample (e.g., urine), transport the fluid sample, and extract a sample of the fluid sample.

[0027] Referring to Figure 1 and Figure 2 , the collection container 22 generally includes a sidewall 30 extending between a first open end 32 and a second closed end 34. The sidewall 30 defines an interior chamber for receiving a fluid sample such as, for example, urine. In one embodiment, the sidewall 30 of the container 22 includes a slightly tapered tubular vessel having a continuous tapered sidewall 30. The open end 32 defines a lip 33 and includes an outer threaded portion 40 about its periphery. The closed end 34 includes a bottom wall 35. In one embodiment, the collection chamber of the container 22 is suitable for holding biohazardous materials. In one embodiment, the sidewall 30 of the collection container 22 can include at least one fill level indicator that identifies the fluid level of the collected fluid sample.

[0028] In one embodiment, the collection container 22 and the container cap 24 can be made from any conventional material such as, for example, polymeric resins. Polymeric resins are well known in the art and include, for example, polyethylene, polycarbonate, polystyrene, and similar polymeric resin materials. However, it is to be understood that the collection container 22 and / or the container cap 24 can be formed from other suitable materials and can be formed from different materials.

[0029] Referring to Figure 1 and Figure 3The container lid 24 generally includes a flange 50 extending around its outer rim, which can provide a tight fit on the collection container 22 when the container lid 24 is placed on the first open end 32 of the collection container 22. The flange 50 of the container lid 24 can include a plurality of ribs 51 disposed on the outer surface of the flange 50. The ribs 51 can provide gripping members to allow a user or tool to more easily grasp the container lid 24 when attaching or detaching the container lid 24 to the collection container 22.

[0030] Additionally, the container lid 24 also includes an elongated receptacle 52 extending into the collection container 22 toward the bottom wall 35 of the collection container 22. The receptacle 52 includes an open end 54 and an opposite lower end 56 with a receiving cavity 60 defined therein. In one embodiment, the receiving cavity 60 is sized and shaped to receive a sample collection tube, such as, for example, an evacuated tube (not shown). In this manner, a fluid sample within the collection container 22 can be transferred to the sample collection tube without the need to remove the container lid 24. Although not shown, in one embodiment, the receptacle 52 includes a needle or cannula configured to pierce a stopper of the sample collection tube to allow the sample to be drawn from the collection container 22 into the sample collection tube. When the container lid 24 is attached to the collection container 22, the needle is well protected within the receptacle 52, as shown in Figure 4B , reducing the risk of a user being stuck by the needle.

[0031] Still referring to Figure 1 and Figure 3 , in one embodiment, the container lid 24 includes a generally disc-shaped member having an outer or peripheral region 62 and an inner or central region 64. The flange 50 extends downwardly from the peripheral region 62 of the container lid 24. As shown in Figure 4A to Figure 5B , the flange 50 includes an inner surface that includes a member or mechanism for sealingly engaging the container lid 24 with the open end 32 of the collection container 22. In one embodiment, the flange 50 includes an internally threaded portion 68, enabling the container lid 24 to be threadably coupled to the open end 32 of the collection container 22 via mating threaded portions 40, 68, as shown in Figure 4B . In other embodiments, the sealing portion of the container lid 24 can include a snap-fit mechanism, a ball detent, an interference fit mechanism, a locking tab, a spring-loaded locking mechanism, a latch, or other similar mechanism to sealingly engage the container lid 24 to the collection container 22 to substantially prevent the fluid sample contained within the collection container 22 and the container lid 24 from leaking out, while also preventing contaminants from entering.

[0032] As shown in Figure 2As shown in FIG. 1, the collection container 22 also includes a stop ring 38 that extends circumferentially around the collection container 22 at a location below the outer threaded portion 40. The stop ring 38 includes an upper surface 39. When the container cap 24 is secured on the collection container 22, the stop ring 38 is configured to prevent over-torquing / over-rotation of the container cap 24 on the collection container 22. Additionally, in one embodiment, the stop ring 38 functions as a secondary sealing surface to prevent fluid leakage from the collection container 22. In particular, referring to Figure 4B , the lower surface 66 of the flange 50 is configured to contact the upper surface 39 of the stop ring 38 when the container cap 24 is fully connected to the collection container 22. In this manner, the upper surface 39 functions as a stop to prevent over-rotation of the container cap 24, which in turn prevents the sealing surface 70 on the container cap 24 from being over-tightened (or "bottomed out") on the lip 33 of the collection container 22. The interface between the upper surface 39 of the stop ring 38 and the lower surface 66 of the flange 50 also functions as a secondary sealing surface in the event of fluid leakage past the interface between the sealing surface 70 and the lip 33.

[0033] As noted above, in conventional container caps and collection containers, the connection interface between the cap and the container is substantially fully sealed, preventing not only fluid(s) in / out, but also air in / out. As a result of this full sealing between the container and the cap, when fluid is withdrawn from the container into an evacuated collection tube, the sample collection tube can become under-filled due to the vacuum created in the headspace of the container above the fluid sample as the fluid is withdrawn from the container. However, referring to Figure 5A and Figure 5B a container cap 24 according to one embodiment of the present disclosure is shown in greater detail, wherein the container cap 24 is configured to prevent or substantially reduce any vacuum created in the headspace of the collection container to which it is coupled.

[0034] In particular, referring to Figure 5B , the sealing interface 70 of the container cap 24 includes a sealing surface region 72. The sealing surface region 72 is a textured or roughened portion of the sealing interface 70 that provides venting to and from the headspace above the fluid sample within the collection container 22. In this manner, when the fluid sample is withdrawn from the collection container assembly 20 via an evacuated tube (not shown), no vacuum is created in the headspace, thereby allowing the evacuated tube to be filled without the resistance that would normally be caused by such a vacuum.

[0035] While the textured sealing surface region 72 allows air to vent into and out of the collection container assembly 20, its permeability is low enough to substantially prevent or minimize fluid leakage even if the collection container assembly 20 is tilted or bumped during transport. The texture on the sealing surface region 72 can be formed by any suitable method, such as, for example, a chemical etching process during injection molding of the container cap 24. Examples of suitable textures include Mold-Tech MT11000, MT11010, and MT11020. However, it should be understood that other textures and / or methods for producing such textures can be utilized according to this disclosure.

[0036] In addition, although Figure 5B The sealing surface region 72 is shown extending along a defined portion of the sealing interface 70, but it should be understood that the sealing surface region 72 may extend more or less across the sealing interface 70 of the container lid 24. Additionally and / or alternatively, although not shown, it should be understood that the collection container 22 may include a textured sealing surface region at the sealing interface between the collection container 22 and the container lid 24.

[0037] Still referencing Figure 5B In one embodiment of this disclosure, the container cap 24 further includes a secondary sealing surface region 74 at the lower surface 66 of the flange 50. Similar to the sealing surface 72 described above, the secondary sealing surface region 74 is textured to allow air to enter and exit the collection container assembly 20 when the container cap 24 is fully attached to the collection container 22 and when the lower surface 66 of the flange 50 contacts the upper surface 39 of the stop ring 38. Thus, while the interface between the upper surface 39 and the lower surface 66 serves to prevent over-tightening and fluid leakage between the container cap 24 and the collection container 22, the textured secondary sealing surface 74 allows for permeability, thereby preventing the formation of a vacuum in the top space above the fluid sample.

[0038] Textures on the secondary sealing surface region 74 can also be formed by any suitable method, such as, for example, a chemical etching process during injection molding of the container lid 24. Examples of suitable textures similar to sealing surface region 72 include, for example, Mold-Tech MT11000, MT11010, and MT11020. However, it should be understood that other textures and / or methods for producing such textures can be utilized according to this disclosure. Additionally and / or alternatively, although not shown, it should be understood that the upper surface 39 of the stop ring 38 may include a textured sealing surface region at the sealing interface between the collection container 22 and the container lid 24.

[0039] While several embodiments of the fluid sample collection container assembly are illustrated in the drawings and described above, other embodiments will be apparent to those of ordinary skill in the art and can be made without departing from the scope and spirit of the application. For example, it will be appreciated that the disclosure contemplates one or more features of any embodiment can be combined with one or more features of any other embodiment. Accordingly, the foregoing description is intended to be illustrative only.

Claims

1. A container assembly for collecting a fluid sample, comprising: a collection container having a first end, a second end, and a sidewall extending between the first end and the second end, and the sidewall defining a chamber for receiving the fluid sample; and a container cap couplable to the collection container to at least partially enclose the first end thereof, wherein the container cap includes an elongated receptacle extending into the chamber of the collection container, the elongated receptacle having an open end defined within an upper surface of the container cap and configured to receive a sample collection tube therein, wherein the container cap includes a sealing interface configured to at least partially contact the collection container when the container cap is coupled to the collection container, and wherein the sealing interface includes a textured sealing surface area configured to allow air to enter or exit the container assembly while maintaining a substantially fluid-tight seal between the container cap and the collection container when the container cap is coupled to the collection container, wherein the textured sealing surface area is formed by a chemical etching process.

2. The container assembly of claim 1, wherein, the container cap is threadably couplable to the collection container.

3. The container assembly of claim 1, wherein, the collection container further includes a stop ring extending circumferentially around the collection container at a location below an externally threaded portion of the collection container.

4. The container assembly of claim 3, wherein the container cap includes a flange extending around an outer rim thereof, and wherein a lower surface of the flange is configured to contact an upper surface of the stop ring when the container cap is fully coupled to the collection container.

5. The container assembly of claim 4, wherein, the lower surface of the flange includes a secondary textured sealing surface area configured to allow air to enter or exit the container assembly when the container cap is coupled to the collection container.

6. The container assembly of claim 5, wherein, the secondary textured sealing surface area is formed by a chemical etching process.

7. The container assembly of claim 4, wherein, the flange includes an internally threaded portion configured to enable the container cap to be threadably coupled to the externally threaded portion of the collection container.

8. The container assembly of claim 4, wherein, the flange includes a plurality of ribs extending circumferentially around the flange.

9. A container cap for use with a container assembly for collecting a fluid sample, the container cap comprising: a disc-shaped perimeter region; a central region located within the perimeter region, wherein the central region includes an elongated receptacle extending downwardly from the central region, the elongated receptacle having an open end defined on an upper surface of the central region and configured to receive a sample collection tube therein; and a flange extending downwardly from the perimeter region, wherein the flange includes an inner surface configured to releasably engage a collection container, and wherein at least a portion of the inner surface includes a textured sealing surface area configured to allow air to enter or exit the container assembly while maintaining a substantially fluid-tight seal between the container cap and the collection container when the container cap is coupled to the collection container, wherein the textured sealing surface area is formed by a chemical etching process.

10. The container lid of claim 9, wherein, The inner surface further includes a threaded portion configured to enable the container cap to be threadably coupled to an externally threaded portion of a collection container.

11. The container cap of claim 9, wherein the flange further includes a lower surface, and wherein the lower surface includes a secondary textured sealing surface area configured to allow air to enter or exit the container assembly when the container cap is coupled to a collection container.

12. The container lid of claim 11, wherein, The secondary textured sealing surface area is formed by a chemical etching process.

13. The container lid of claim 9, wherein, The flange includes a plurality of ribs extending circumferentially around the flange.

14. A method of forming a container assembly for collecting a fluid sample, the method comprising: providing a collection container having a first end, a second end, and a sidewall extending between the first end and the second end, and the sidewall defining a chamber for receiving the fluid sample; and providing a container cap couplable to the collection container to at least partially enclose the first end thereof, wherein the container cap includes an elongated receptacle extending downwardly therefrom, the elongated receptacle configured to receive a sample collection tube therein, and wherein the container cap further includes a flange extending around an outer rim thereof, wherein an inner surface of the flange has a textured sealing surface area formed thereon, wherein the textured sealing surface area is formed by a chemical etching process, wherein the textured sealing surface area of the container cap contacts a surface of the collection container when the container cap is coupled to a collection container so as to allow air to enter or exit the container assembly while maintaining a substantially fluid-tight seal with the collection container.

15. The method of claim 14, further comprising forming a stop ring extending circumferentially around the collection container.

16. The method of claim 15, further comprising forming a secondary textured sealing surface area on a lower surface of the flange, wherein the lower surface of the flange is configured to contact an upper surface of the stop ring when the container cap is fully coupled to a collection container.

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